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EITAGlobal to organize webinar on “Using SharePoint as a Technology Platform for 21 CFR Part 11 –a C

Education

(Free Press Release) EITAGlobal, a leading continuing education training provider in the IT space, will organize a webinar on January 17, 2014 on the topic, “Using SharePoint as a Technology Platform for 21 CFR Part 11 –a Case Study”. Richard Machanoff, Owner and Sr. Consultant at Machanoff CIO Services, will be the Speaker at this session.

EITAGlobal to organize webinar on “Using SharePoint as a Technology Platform for 21 CFR Part 11 –a C


      

This webinar charts a strategy for complying with the FDA 21 CFR Part 11 regulation using SharePoint.

 

A startup biotech company, with plans to eventually conduct Phase III clinical trials, realized that an attempt to maintain paper records for a Phase III trial would be overwhelming. Just keeping up with the paper records for their first Phase I and Phase II trials was daunting. The company’s executives estimated that it would take at least five years to mature the corporate quality program, IT infrastructure and Information Systems to reach the goal of using electronic records and electronic signatures that complied with the 21 CFR Part 11 regulation for FDA submissions. With phase III trials planned within three years, they needed a strategy to comply with Part 11 guidelines in a much shorter timeframe. Employing SharePoint as a compliance framework, they were able to meet their schedule.

Using this biotech company as a case study, the webinar charts a strategy for complying with the FDA 21 CFR Part 11 regulation using SharePoint. The rationale for choosing SharePoint as the compliance platform for generating and maintain electronic records and electronic signatures for FDA submissions is discussed with a brief overview of a SharePoint-based approach for:

o SOP and Training Management

o Regulatory Submissions

o Clinical Trial Management

o Product Management

o Electronic Signature System

The following areas are covered in this webinar:

  • Introduction and about the presenter
  • 21 CFR Part 11 considerations
  • Description of the Biotech company used for the Case Study
  • IT Controls
    • Policy, Plans, and Procedures
    • Systems that support PPP
  • Data Center Design and Data Center Qualification
  • Document Management System Selection
  • Using SharePoint as a Compliance Platform
    • SOP and Training Management
    • Regulatory Submissions
    • Clinical Trial Management
    • Product Management
    • Electronic Signature System
  • System Validation
    • Computer System Master Validation Plan
    • Establishing a process for system validation
  • Lessons Learned

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When: January 17, 2014, 10:00 AM PST | 01:00 PM EST

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By whom:

Richard Machanoff is Owner and Sr. Consultant at Machanoff CIO Services and Fellow at Technology Strategies at Oak Ridge Strategy Group. Richard is an Information technology leader with diverse, executive-level experience and a talent for identifying business requirements and delivering innovative cost effective IT solutions.

 

As technology strategist, he works with top leadership to expand company capabilities and continuously improve efficiency. He has a track record of developing and implementing technology strategies that support organizational goals and streamline operations.

 

Mr. Machanoff holds a B.S. in microbiology, biochemistry, and chemistry from the University of Tennessee, Knoxville and an M.S. in molecular genetics from the University Of Tennessee Oak Ridge Graduate School Of Biomedical Sciences, Oak Ridge. He is ITIL Foundations certified and currently holds an active US DOE Q clearance.

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For whom:

The webinar will benefit

o CIO

o COO

o IT Director, IT Manager

o Project Managers

o Business Unit Mangers

o CFO

o QA and QC Directors/Managers

o Document Managers and Knowledge Managers

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Duration: 90 minutes

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To enroll for this webinar, contact

This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Ph: 800-447-9407

Fax: 302-288-6884

 

 




EITAGlobal to organize webinar on “Using SharePoint as a Technology Platform for 21 CFR Part 11 –a C

Source: Press Release

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